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EC number: 203-786-5 | CAS number: 110-63-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- According to the NTP protocol animals were treated for 5 days per week. No clinical pathology parameters were examined.
- GLP compliance:
- yes
Test material
- Reference substance name:
- γ-butyrolactone
- EC Number:
- 202-509-5
- EC Name:
- γ-butyrolactone
- Cas Number:
- 96-48-0
- Molecular formula:
- C4H6O2
- IUPAC Name:
- oxolan-2-one
- Details on test material:
- - Name of test material (as cited in study report): γ-Butyrolactone
- Physical state: liquid
- Analytical purity: 97.92%
- Impurities (identity and concentrations): 11 impurities were identified by GC method, there is no data on chemical identity of these impuries.
- Stability under test conditions: stable
- Storage condition of test material: stored at 5°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female F344/N rats, obtained from Charles River Breeding Laboratories (Kingston, NY). The average age of rats was 51 days old at the beginning of the study. Animals were observed for 19 days before the study started. Rats were housed five to a solid-bottom polycarbonate cage and the light cycle was 12-hour light and dark. Temperature was maintained between 22-24 deg C with RH of 35-62%.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 56, 112, 225, 450, or 900 mg/kg bw
Basis:
other: by gavage in 5 mL corn oil
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Animals were observed twice a day and clinical observations were recorded once a week. Animals were weighed at the start of the study and weekly thereafter.
- Sacrifice and pathology:
- Surviving animals were killed at the end of the 13-week studies. Necropsies were performed on all study animals. The brain, heart, right kidney, liver, lungs, and thymus of survivors were weighed at necropsy. Complete histopathology was performed on all animals killed or dying during the study, all control animals, rats receiving 900 mg/kg, male rats receiving 450 mg/kg. The liver and nose (nasal cavity and turbinates) were examined from rats in the 56, 112, and 225 mg/kg dose groups and from female rats in the 450 mg/kg dose groups. Tissues routinely examined include: adrenal gland, bone and marrow (femur), brain, clitoral gland, esophagus, epididymis, heart, kidney, large intestine, liver, lung with mainstem bronchi, lymph nodes (mesenteric, mandibular), mammary gland, nasal cavity and turbinates, ovary, pancreas, parathyroid gland, pituitary gland, prostate gland, salivary gland, seminal vesicle, skeletal muscle (thigh), skin, small intestine, spleen, stomach, testis, thymus, thyroid gland, trachea, urinary bladder, uterus, and gross lesions and tissue masses (with regional lymph nodes).
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- males and females at 900 mg/kg became recumbent several minutes after dosing but were normal at next observation.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- males and females at 900 mg/kg became recumbent several minutes after dosing but were normal at next observation.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- males given 450 mg/kg had decreased mean body weights and body weight gains.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 225 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Based on body weights. No specific target organs were identified.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 450 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Based on 1 death in the 900 mg/kg group. No specific target organs were identified.
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
All high-dose males and one high-dose female died. Males receiving 450 mg/kg gained less body weight. There was no body-weight effect in females at any dose level. Other than inflammation of the nasal mucosa in all groups of dosed rats, there were no specific organ effects. The nasal mucosa irritation was considered to be a non-specific effect of gavage with a volatile agent. NTP reports that similar lesions have been observed in other NTP gavage studies with a variety of chemicals and that the lack of any histologically evident degenerative lesions may be attributed in part to the rapid absorption and metabolism of the chemical.
Rats at the higher dose levels (225 mg/kg and above) showed signs of sedation after dosing during the first 2-3 weeks of study that diminished in intensity with continued dosing, and rats showed no visible signs of sedation after three weeks of dosing. While this effect is clearly attributable to the test substance, it is not considered relevant to establishing a chronic NOAEL for workers or consumers except in cases of accidental poisoning.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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